Upcoming Events

Posted in :: 2021 Volume 1 :: Friday, January 29th, 2021

To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.

FACT Inspection and Accreditation Workshop
February 4, 2021

This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop.  Information will interest initial applicants and those who have attended previously.

Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.

Workshop Objectives:
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.

Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.

Register for the virtual workshop

FACT-ASTCT Quality Boot Camp
February 5, 2021

Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.

Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example.  “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:

  • Perform a Facility Needs Assessment
  • Develop a Change Control
  • Execute Risk Assessments
  • Determine what to Validate and Audit
  • Perform Validation(s)
  • Establish Quality Indicators
  • Perform Audits

At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.

Register for the virtual boot camp


FACT Announces Upcoming Virtual Events

Posted in :: 2020 Volume 9 :: Monday, December 14th, 2020

To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.

FACT Inspection and Accreditation Workshop
February 4, 2021

This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop.  Information will interest initial applicants and those who have attended previously.

Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.

Workshop Objectives:
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.

Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.

Register for the virtual workshop

FACT-ASTCT Quality Boot Camp
February 5, 2021

Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.

Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example.  “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:

  • Perform a Facility Needs Assessment
  • Develop a Change Control
  • Execute Risk Assessments
  • Determine what to Validate and Audit
  • Perform Validation(s)
  • Establish Quality Indicators
  • Perform Audits

At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.

Register for the virtual boot camp


View the FACT Virtual Workshop that Everyone is Talking About

Posted in :: 2020 Volume 9 :: Friday, December 11th, 2020

As reported in a previous newsletter article, the first FACT Inspection & Accreditation Virtual Workshop on September 21, 2020 was well received by those in attendance, and we are pleased to provide everyone with an opportunity to view the recording of the workshop.

The workshop began with an overview of the FACT accreditation process and continued with hands-on activities to guide the applicant through the accreditation process. Workshop objectives include:

  • Describe the accreditation process.
  • Evaluate documentation to ensure compliance.
  • Organize the on-site inspection process.
  • Plan a program tour.
  • Identify strategies to support a successful inspection.
  • Practice evaluating deficiencies.

A digital download of the workshop recording can be purchased from the FACT online store at competitive prices. As always, inspectors and inspector trainees may download the recording for free!

Purchase the virtual workshop recording


FACT-SBTMO Accreditation Virtual Workshop for Transplant Programs in Brazil

Posted in :: 2020 Volume 9 :: Monday, December 7th, 2020

The second edition of the FACT-SBTMO Accreditation Workshop for transplant centers in Brazil occurred during an online event on October 27, 2020. The pre-conference event took place prior to the SBTMO 2020 Congress and was simulcast in both Portuguese and English. The virtual platform enabled program personnel throughout Brazil to participate in the workshop. Interactive sessions provided an overview of FACT Cellular Therapy Standards, emphasized the importance of a quality management program including document control and validation, and addressed areas that are challenging for new centers. Members from Hospital Israelita Albert Einstein, the first FACT-accredited program in Brazil, shared their experience in organizing and preparing for a successful inspection and accreditation process. Nearly 40 transplant centers in Brazil have expressed their interest and commitment to improving quality and safety through the FACT-SBTMO accreditation program.


FACT-SBTMO workshop presenters enjoy interacting with workshop participants. Pictured from top to bottom are Andrea Kondo, Carlos Bachier, Carlos Ramos, Phyllis Warkentin, and Daniel Kota.


FACT Invites You to Join Us for a Webinar in Support of World Cord Blood Day

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Monday, November 16, 2020 at 10:00 am ET, 15:00 GMT. The purpose of this webinar is to discuss the current progress using UM171-expanded cord blood transplantation, as well as to understand the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. This webinar is 90-minutes, complimentary, and will be presented in French. Slides will be available in both English and French.

Presenters include:

  • Maude Dumont-Lagacé, PhD, a clinical scientist at ExCellThera Inc. (Canada)
  • Catherine Faucher, Md, clinical hematologist and currently in charge of the strategic pole “collection and transplantation of HSC” at the Agence de Biomédecine. (France)

FACT also encourages you to join the Save the Cord Foundation on November 17 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 16:

  1. Log into Webinar: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Meeting ID: 922 6984 5238
  3. Passcode: WCBD

_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon, FACT vous invite à participer à un webinaire spécial le lundi 16 Novembre 2020 à 10.00 ET, 15:00 GMT. L’objectif de ce webinaire est de discuter les progrès récents liés à l’utilisation de la méthode d’expansion de cellules UM171 en transplantation de sang de cordon, et également de comprendre l’effet de la pandémie COVID-19 sur la collecte et la transplantation de sang de cordon en France. Ce webinaire de 90 minutes est gratuit et sera présenté en français. Les orateurs seront:

  • Maude Dumont-Lagacé, PhD, Spécialiste en Sciences Cliniques à ExCellThera Inc (Canada)
  • Catherine Faucher, MD, Hématologue Clinicienne, actuellement en charge du pôle “Prélèvement et greffes de CSH” à l’Agence de biomédecine (France)

FACT vous encourage également à rejoindre la Fondation Save the Cord le 17 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations d’introduction pour le public et des présentations académiques par des chercheurs et médecins transplanteurs renommés, sur les dernières avancées et les traitements utilisant le sang de cordon.

Instructions pour rejoindre le webinaire le 16 Novembre:

  1. Connexion au webinaire: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Identification de la conférence: 922 6984 5238
  3. Mot de passe: WCBD

FACT Inspection & Accreditation Virtual Workshop an Interactive and Educational Success

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT’s first Inspection & Accreditation Virtual Workshop, hosted on September 21, 2020, was a great success! FACT thanks the workshop chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH; the FACT Education Committee, the presenters, and the attendees for bringing energy and enthusiasm to this important educational event. A culture of quality is as important now as it ever was, and we enjoyed being “with” the FACT community again!

Please Complete the Workshop Evaluation

If you attended the workshop, please tell us everything! We are always striving to provide a great educational experience.  As part of this, we would appreciate feedback on FACT’s first virtual workshop so we can improve and make the next virtual event even better.

Complete virtual workshop evaluation

Summary

Workshop Registrants

The Foundation for the Accreditation of Cellular Therapy hosted its first virtual inspection and accreditation workshop on September 21, 2020.  The workshop included two tracks, apheresis collection and cord blood banking. Attendance included 165 workshop registrants, 35 FACT staff members and Matrix Maxx staff members, and 19 workshop presenters and moderators. The breakdown of the 165 attendees is illustrated below:

Registrants from 18 different countries attended, including:

Lunch with Leaders

Participants were able to ask any question to FACT leaders during the Lunch with Leaders session.

Favorite Parts of the Day

In addition to these favorite parts of the day, attendees enjoyed feeling connected with the international FACT community during this challenging year and felt the workshop was one of the most interactive and engaging virtual conferences. Attendees also felt that the workshop was comprehensive and educational despite being virtual.

Workshop Programming

The workshop included pre-recorded presentations, live question and answer sessions, interactive activities requiring audience participation, and a live tour of an apheresis unit and cord blood bank.

Participants were able to ask questions at any time via the workshop chat feature.  Each track included a moderator; Dr. Dennis Gastineau moderated the apheresis track and Dr. Kim Kasow moderated the cord blood track.   Dr. Gastineau and Dr. Kasow were able to monitor presentation chat questions and interact with the presenters to ensure all questions were answered.

Participants joined in polling sessions, which allowed them to participate in analyzing case studies on both workshop tracks.


Calling All Cord Blood Banking Professionals!

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!

Workshop presenters have a special message for all cord blood banking professionals below.

We hope to see you at FACT’s very first virtual workshop on September 21st!


Calling All Apheresis Professionals!

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!

Workshop presenters have a special message for all apheresis professionals below.

We hope to see you at FACT’s very first virtual workshop on September 21st!


Upcoming Quality Management Series Module 10: Validation

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation

Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation
TBA

Register for the entire series to receive a 15% discount! 

Module 10 includes all of the upcoming webinars and the recording of the first webinar:

Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Purchase recording now


Registration is Open for the FACT Inspection & Accreditation Virtual Workshop!

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

September 15, 2020 – 8:00 am to 3:00 pm CDT/13:00 to 20:00 GMT

 

When one door closes, another one opens – and FACT’s first ever Inspection & Accreditation Virtual Workshop makes these words ring true! We wish all of our stakeholders good health and safety, and are pleased to offer a new workshop format to allow us all to come together again. After all, learning never ends.

The workshop co-chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH, have been working hard with the FACT Education Committee and the international panel of presenters to offer an elegant and interactive learning experience. Registrants can choose either the cord blood or apheresis track, and will also have the opportunity to ask questions directly to leaders in accreditation, cord blood, or apheresis in the Lunch with Leaders session.

Following a combination of presentations, recordings, activities, games, and discussions; workshop attendees will leave the event being able to:

  • Describe the accreditation process.
  • Evaluate documentation to ensure compliance.
  • Organize the on-site inspection process.
  • Plan a program tour.
  • Identify strategies to support a successful inspection.
  • Practice evaluating deficiencies.

The year 2020 has made it even more obvious that a culture of quality is critical to providing quality patient care. With no travel required and low registration fees, several colleagues at your institutions can register for the event, thereby developing an even deeper understanding of FACT accreditation at your program.

“See” you at the workshop!

View workshop details

See workshop agenda

Register for the workshop


Upcoming Educational Events

Posted in :: 2020 Volume 6 :: Friday, August 21st, 2020

Register now:

Bringing a Stand-Alone Immune Effector Cell therapy Program into FACT Compliance

 

Upcoming Quality Management Series Module 10: Validation

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation

Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation

TBA

Register for the entire series to receive a 15% discount! 

Module 10 includes all of the upcoming webinars and the recording of the first webinar:

Validation Overview

Presented by Nicole Prokopishyn, PhD

August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.


SAVE THE DATE: FACT Announces Virtual Inspection & Accreditation Workshop

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020


Quality Management Series, Module 10: Validations

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

The Quality Management Series Module 10 includes four sessions focused on Validation including:

Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Register now

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation
Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation
TBA

Register for the entire module to receive a 15% discount! QM Series Module 10: Validations


FACT-CBA Webinar: The Effect of the COVID-19 Pandemic on Cord Blood Banking

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT

Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:

Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing

Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.

Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom

Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.

Arvin Faundo, MD
Cordlife Group Limited, Singapore

Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.

Donna Regan MT(ASCP), SBB
NMDP

Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.

Lydia Foeken, LN
WMDA, Executive Director

Register now:
The Effect of the COVID-19 Pandemic on Cord Blood Banking


New Immune Effector Cellular Therapy Webinar: Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

Register now:
Bringing a Stand-Alone Immune Effector Cell therapy Program into Compliance


Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020


Canceled: FACT Cellular Therapy Collection Inspection and Accreditation Workshop

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

The American Society for Apheresis (ASFA) Board of Directors has decided not to proceed with the ASFA 2020 Annual Meeting, originally scheduled for May 6 – 9, 2020 in Austin, Texas due to the coronavirus (COVID-19) outbreak.

For the same considerations, the associated FACT Cellular Therapy Collection Inspection and Accreditation Workshop scheduled for May 6, 2020 has also been cancelled.

The ASFA Board of Directors is currently assessing the feasibility of rescheduling the Annual Meeting for later this year. If ASFA reschedules the annual meeting, the FACT workshop will also be rescheduled. Your payment will be applied to the new FACT Collection Inspection and Accreditation Workshop date. If the meeting is not rescheduled for 2020, your payment can be applied to the FACT workshop at the 2021 ASFA Meeting. If you prefer to receive a refund, please contact the FACT Business Manager, Jay Ann Witt at jawitt@unmc.edu.

The health and well-being of our cellular therapy community, volunteers, staff, and patients is our utmost concern. We look forward to seeing you at our next workshop. If you have questions, please do not hesitate to contact the FACT Office.